Content about Biosimilar

WHITEHOUSE STATION, N.J. — Drug maker Merck and drug industry services organization Parexel International will work together to develop biosimilars, the two said Wednesday.

Under the agreement, Parexel will give Merck BioVentures access to clinical and regulatory services for the development of biosimilars. Financial terms of the agreement were not disclosed.

SILVER SPRING, Md. — Drugs for bacterial infections and cancer, and one that could help shape regulations for biosimilars, are featured in the Food and Drug Administration’s annual "Generic Drug Roundup."

The roundup is an annual highlighting of what the agency considers the most significant generic drug approvals.

WALTHAM, Mass. — William Gibson, the science-fiction author who helped create the cyberpunk genre in the 1980s and paved the way for “The Matrix” movie franchise, once said, “The future is already here—it’s just not evenly distributed.”

He was correct. Emerging technologies, ranging from computers to mobile phones, historically have migrated from the theoretical to the inaccessible to the aristocratic to the indispensable and finally to the mundane.

SILVER SPRING, Md. The main lobbies for the biotechnology and generic drug industries, and a leading manufacturer of generic drugs, testified Wednesday at a hearing sponsored by the Food and Drug Administration to collect public and industry input on the implementation of the regulatory approval pathway for follow-on biologics included in the healthcare-reform bill.

WOONSOCKET, R.I. In testimony before the Food and Drug Administration on Tuesday, CVS Caremark’s SVP specialty pharmacy operations, Scott Reid, reiterated the company’s support that the FDA implement regulations necessary to approve biogeneric drugs under the Affordable Care Act.

JERUSALEM The Food and Drug Administration declined to approve a Teva biosimilar, the generic drug maker said Thursday.

Teva said it received a complete response letter from the FDA concerning Neutroval (filgrastim), for neutropenia in patients receiving chemotherapy for cancer. The FDA issues complete response letters when it needs additional information before it can approve a drug.

Neutroval is a biosimilar of Amgen’s Neupogen and is marketed in Europe under the name TevaGrastim.

WASHINGTON The Food and Drug Administration is looking for input on regulations concerning knock-off versions of biotech drugs, according to published reports.

The Hill, a newspaper in Washington, reported Monday that the FDA would have a hearing on Nov. 2 and 3 concerning follow-on biologics, based on a draft document distributed to healthcare lobbyists.

According to the report, the hearing would focus on such issues as interchangeability and definitions of such terms as “biological product.”

SOMERSET, N.J. A lot of generic drug companies have conducted business in the branded drug market on the side for a long time, with Teva Pharmaceutical Industries and Watson Pharmaceuticals standing out as good examples. But lately, some branded drug companies have sought to get into generics as well.

Meda Pharmaceuticals, the U.S. subsidiary of Swedish drug maker Meda A.B., recently decided to create its own generics subsidiary, calling it Wallace Pharmaceuticals, senior marketing director John White told Drug Store News.